Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities (EPIC)

This study is currently recruiting participants.
Verified April 2014 by AbbVie
Sponsor:
Collaborator:
Mag. Andreas Raffeiner GMBH
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01401452
First received: July 1, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

The aim of this post-marketing observational study (PMOS) is the assessment of effectiveness of Adalimumab in moderate to severe Plaque Psoriasis patients with distinct co-morbidities and impact of Adalimumab on the quality of life in routine clinical praxis over the period of 9 month. Psoriasis is associated with several co-morbidities such as depression, obesity and metabolic syndrome. Until now it is unclear if these co-morbidities are due to the pathophysiology of psoriasis or psoriasis-associated behaviors (e.g. smoking and alcohol abuse). Disease severity is correlated with smoking and alcohol abuse. The severity of psoriasis shall be established before and under treatment of Adalimumab by calculation of the Psoriasis Area Severity Index (PASI) and the analysis of Dermatology Life Quality Index (DLQI) in Patients with at last one co-morbid disease and/or symptom. Also the prevalence of co-morbidities in consideration of gender and other parameters of Life Quality (SF-36) and Life-Quality for specific co-morbidities should be evaluated.


Condition
Moderate to Severe Plaque Psoriasis
Antibodies
Monoclonals

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • To evaluate the effectiveness of Adalimumab over a period of 9 month by analyzing the Psoriasis Area & Severity Index (PASI) in moderate to severe Plaque Psoriasis patients with distinct co-morbidities [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  • Psoriasis Area & Severity Index (PASI) (=Inclusion visit) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.

  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 1 ] [ Designated as safety issue: No ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.

  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 3 ] [ Designated as safety issue: No ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.

  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.

  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 9 ] [ Designated as safety issue: No ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.


Secondary Outcome Measures:
  • Dermatology Life Quality Index (DLQI) (=Inclusion visit) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Subjects will complete a DLQI questionnaire at study visits.

  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 1 ] [ Designated as safety issue: No ]
    Subjects will complete a DLQI questionnaire at study visits.

  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 3 ] [ Designated as safety issue: No ]
    Subjects will complete a DLQI questionnaire at study visits.

  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    Subjects will complete a DLQI questionnaire at study visits.

  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 9 ] [ Designated as safety issue: No ]
    Subjects will complete a DLQI questionnaire at study visits.

  • Evaluation of the prevalence of co-morbidities in consideration of gender (=Inclusion visit) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Life Quality (=Inclusion visit) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)

  • Life Quality [ Time Frame: month 1 ] [ Designated as safety issue: No ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)

  • Life Quality [ Time Frame: month 3 ] [ Designated as safety issue: No ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)

  • Life Quality [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)

  • Life Quality [ Time Frame: month 9 ] [ Designated as safety issue: No ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)

  • Evaluation of the minimum of clinical important differences (MCID) (=Inclusion visit) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 1 ] [ Designated as safety issue: No ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 3 ] [ Designated as safety issue: No ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 9 ] [ Designated as safety issue: No ]

Estimated Enrollment: 266
Study Start Date: August 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with psoriasis with at last one co-morbid disease
Patients with moderate to severe plaque psoriasis with at last one co-morbid disease and/or symptom such as hypertension, Psoriasis Arthritis confirmed by a rheumatologist, obesity, diabetes, metabolic syndrome or depression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital, Dermatology

Criteria

Inclusion Criteria:

Patients for whom Adalimumab therapy is indicated and has been prescribed according to the product label and who meet the following criteria:

  1. Patients age >= 18 years
  2. Moderate to severe Plaque Psoriasis patients with at last one co-morbid disease and/or symptom such as hypertension, Psoriasis Arthritis confirmed by a rheumatologist, obesity, diabetes, metabolic syndrome or depression.
  3. Adalimumab naïve patients with moderate to severe Plaque Psoriasis after unsatisfactory response or non tolerability or contraindication of systemic therapies such as ciclosporin, methotrexate or PUVA ( psoralen + UVA) or after biological disease modifying anti-rheumatic drugs (BDMARDs) failure (e.g.: infliximab, etanercept or ustekinumab)
  4. Patients must fulfill Austrian Treatment Recommendations for use of BDMARD in Psoriasis (Chest X-ray and IGRA* interferon gamma release assay or PPD-skin test negative for tuberculosis)
  5. Patient is willing to consent to data anonymous being collected and provided to Abbott.
  6. Patient must be able and willing to self-administer Adalimumab injections or have a qualified person available to administer Humira® syringe or Humira® Pen injections.

Exclusion Criteria:

The following patients will not be included in this observational study:

  1. Patients who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SPC) and Humira Pen® SPC.
  2. Patients participating in another study program or clinical trial.
  3. Patients who have been treated with Humira® before.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401452

Contacts
Contact: Michaela Mayrhofer-Iro +43-1-20-589-382 michaela.mayrhofer-iro@abbvie.com
Contact: Astrid Dworan-Timler, MD +43-1-89-122-391 astrid.dworan-timler@abbvie.com

Locations
Austria
Site Reference ID/Investigator# 103475 Withdrawn
Feldkirch, Austria, 6807
Site Reference ID/Investigator# 67422 Active, not recruiting
Graz, Austria, 8010
Site Reference ID/Investigator# 80173 Active, not recruiting
Laakirchen, Austria, 4663
Site Reference ID/Investigator# 67426 Active, not recruiting
St. Poelten, Austria, 3100
Site Reference ID/Investigator# 73313 Withdrawn
Vienna, Austria, 1030
Site Reference ID/Investigator# 67424 Active, not recruiting
Vienna, Austria, 1090
Site Reference ID/Investigator# 67425 Active, not recruiting
Vienna, Austria, 1030
Site Reference ID/Investigator# 69663 Active, not recruiting
Vienna, Austria, 1100
Site Reference ID/Investigator# 67428 Withdrawn
Vienna, Austria, A-1030
Site Reference ID/Investigator# 67423 Active, not recruiting
Vienna, Austria, 1090
Site Reference ID/Investigator# 49966 Active, not recruiting
Wels, Austria, 4600
Site Reference ID/Investigator# 67427 Active, not recruiting
Wiener Neustadt, Austria, 2700
Greece
Site Reference ID/Investigator# 104335 Recruiting
Athens, Greece, 16121
Principal Investigator: Site Reference ID/Investigator# 104335         
Site Reference ID/Investigator# 104337 Not yet recruiting
Athens, Greece, 12462
Principal Investigator: Site Reference ID/Investigator# 104337         
Site Reference ID/Investigator# 104595 Recruiting
Athens, Greece, 16121
Principal Investigator: Site Reference ID/Investigator# 104595         
Site Reference ID/Investigator# 104339 Recruiting
Athens, Greece, 11525
Principal Investigator: Site Reference ID/Investigator# 104339         
Site Reference ID/Investigator# 104341 Not yet recruiting
Athens, Greece, 15123
Principal Investigator: Site Reference ID/Investigator# 104341         
Site Reference ID/Investigator# 104340 Not yet recruiting
Chania, Crete, Greece, 73200
Principal Investigator: Site Reference ID/Investigator# 104340         
Site Reference ID/Investigator# 116381 Not yet recruiting
Heraklion Crete, Greece, 71110
Principal Investigator: Site Reference ID/Investigator# 116381         
Site Reference ID/Investigator# 104596 Recruiting
Larissa, Greece, 41100
Principal Investigator: Site Reference ID/Investigator# 104596         
Site Reference ID/Investigator# 104597 Not yet recruiting
Pireas, Greece, 18536
Principal Investigator: Site Reference ID/Investigator# 104597         
Site Reference ID/Investigator# 104336 Not yet recruiting
Thessaloniki, Greece, 54643
Principal Investigator: Site Reference ID/Investigator# 104336         
Site Reference ID/Investigator# 104338 Not yet recruiting
Thessaloniki, Greece, 564 29
Principal Investigator: Site Reference ID/Investigator# 104338         
Israel
Site Reference ID/Investigator# 102740 Not yet recruiting
Beer Sheba, Israel
Principal Investigator: Site Reference ID/Investigator# 102740         
Site Reference ID/Investigator# 102741 Not yet recruiting
Haifa, Israel
Principal Investigator: Site Reference ID/Investigator# 102741         
Site Reference ID/Investigator# 102738 Not yet recruiting
Jerusalem, Israel
Principal Investigator: Site Reference ID/Investigator# 102738         
Site Reference ID/Investigator# 102735 Not yet recruiting
Kfar Saba, Israel
Principal Investigator: Site Reference ID/Investigator# 102735         
Site Reference ID/Investigator# 102742 Not yet recruiting
Kiryat Bialik, Israel
Principal Investigator: Site Reference ID/Investigator# 102742         
Site Reference ID/Investigator# 102737 Not yet recruiting
Netivot, Israel
Principal Investigator: Site Reference ID/Investigator# 102737         
Site Reference ID/Investigator# 102739 Not yet recruiting
Petach Tikva, Israel
Principal Investigator: Site Reference ID/Investigator# 102739         
Site Reference ID/Investigator# 102736 Not yet recruiting
Tel Aviv, Israel
Principal Investigator: Site Reference ID/Investigator# 102736         
Portugal
Site Reference ID/Investigator# 102746 Not yet recruiting
Braga, Portugal, 4710-243
Principal Investigator: Site Reference ID/Investigator# 102746         
Site Reference ID/Investigator# 102756 Not yet recruiting
Lisbon, Portugal, 1649-035
Principal Investigator: Site Reference ID/Investigator# 102756         
Site Reference ID/Investigator# 102758 Not yet recruiting
Lisbon, Portugal, 1069-166
Principal Investigator: Site Reference ID/Investigator# 102758         
Site Reference ID/Investigator# 102757 Not yet recruiting
Lisbon, Portugal, 1169-050
Principal Investigator: Site Reference ID/Investigator# 102757         
Site Reference ID/Investigator# 102743 Not yet recruiting
Porto, Portugal, 4200-319
Principal Investigator: Site Reference ID/Investigator# 102743         
Site Reference ID/Investigator# 102744 Not yet recruiting
Porto, Portugal, 4099-001
Principal Investigator: Site Reference ID/Investigator# 102744         
Site Reference ID/Investigator# 102755 Not yet recruiting
Santarem, Portugal, 2005-177
Principal Investigator: Site Reference ID/Investigator# 102755         
Site Reference ID/Investigator# 102745 Not yet recruiting
Vila Nova de Gaia, Portugal, 4400-129
Principal Investigator: Site Reference ID/Investigator# 102745         
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Mag. Andreas Raffeiner GMBH
Investigators
Study Director: Astrid Dworan-Timler, MD AbbVie Austria
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01401452     History of Changes
Other Study ID Numbers: P12-770
Study First Received: July 1, 2011
Last Updated: April 8, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by AbbVie:
Co-morbidities
Antibodies
Disease Life Quality Index (DLQI)
Adalimumab
Monoclonals
Moderate to severe plaque psoriasis
Psoriasis Area & Severity Index (PASI)
Biological disease modifying anti-rheumatic drugs (BDMARD)

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 23, 2014